Dutasteride

Product NDC

60505-3877

11-digit product format

605053877

Labeler code

60505

Product ID

60505-3877_b844f61e-c11e-ccee-6f5d-34fc5ca0d8b4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

dutasteride

Dosage form

CAPSULE, LIQUID FILLED

Route

ORAL

Labeler

Apotex Corp.

Application

ANDA204292

Marketing category

ANDA

Marketing start

2015-11-25

Marketing end

2021-01-31

Substance

DUTASTERIDE

Active strength

1 mg/1

Pharmacologic classes

5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record